Clinical Trial Studies usually involve the development of Visit Specific Kits (VSK’s™) that will be sent to an Investigator site on a scheduled basis. Therapak is the leading outsourcing partner that will help you design, develop and distribute VSK’s™ according to cGMP (Current Good Manufacturing Practices) quality system requirements.
Therapak’s Project Managers are experienced individuals who have managed and processed clinical trial studies for biotechnology firms, commercial clinical trial testing laboratories and pharmaceutical companies worldwide. Overall, Therapak is very familiar with troubleshooting protocols to help clients develop a visit based schedule for lab kits that serve the purpose of monitoring patients involved in a clinical study on an investigational drug.
Beyond managing the VSK™ development process, Therapak typically governs all aspects of shipping the kits to the investigator sites throughout the study as a distribution function. The VSK’s™ and all associated bulk supplies, requisitions, airbills, dangerous goods documentation and shipping supplies are coordinated at Therapak by the assigned Project Manager and shipped to the site. As patients show up according to the visit schedule, specimens are packaged and shipped directly to the designated testing facility that performs the lab work and results reporting for the study.
As a GMP production facility, Therapak offers turnkey services for the procurement of finished medical devices, inventory, manufacturing, storage and distribution of customized visit specific kits for the biotechnology and pharmaceutical industry.
Therapak stocks hundreds of products for use in the assembly of clinical trial kits. From transport boxes to evacuated blood tubes to cryogenic tubes to labeling, Therapak has the experience and understands the timelines necessary to assist in the management of clinical trial kit packaging and site distribution.
Whether you have visit oriented kits, pharmacokinetic timepoint specific kit or bulk supplies, Therapak can help you customize site-friendly packaging for outbound and inbound shipping. All kit components are packaged in a sealed bag to protect the integrity of the components. Whether the kit is in a box or presented in the bag to the site, protocol labels identifying the Sponsor name, part number, visit description, timepoint, lot number and expiration date are developed by Therapak and applied to the bag or box as specified. Multiple visit or timepoint kits can also be packaged in large dispenser boxes for easy use at the collection site.